Fluorescein 100 mg/ml Solution for injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Fluorescein sodium

Available from:

Pharmargus Limited

ATC code:

S01JA01

INN (International Name):

Fluorescein sodium

Dosage:

100 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Therapeutic area:

fluorescein

Authorization date:

2021-08-27

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
FLUORESCEIN 100 MG/ML SOLUTION FOR INJECTION
fluorescein (as sodium)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, please ask your doctor.
-
If you get any side effects, talk to your doctor. This includes any
possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Fluorescein 100 mg/ml Solution for injection is and what it is
used for
2.
What you need to know before you are given Fluorescein 100 mg/ml
Solution for injection
3.
How Fluorescein 100 mg/ml Solution for injection is given
4.
Possible side effects
5.
How to store Fluorescein 100 mg/ml Solution for injection
6.
Contents of the pack and other information
7.
Information for the Health care professional
1.
WHAT FLUORESCEIN 100 MG/ML SOLUTION FOR INJECTION IS AND WHAT IT IS
USED FOR
Fluorescein 100 mg/ml Solution for injection is a dye solution that
makes the blood vessels at
the back of your eye visible during an eye examination (this procedure
is known as fluorescein
angiography). This medicine is for diagnostic use only. It is not used
to treat any condition.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN FLUORESCEIN 100 MG/ML
SOLUTION FOR
INJECTION
YOU SHOULD NOT BE GIVEN FLUORESCEIN 100 MG/ML SOLUTION FOR INJECTION:
-
if you are allergic (hypersensitive) to fluorescein or any other
ingredients of this medicine
(listed in section 6).
Tell your doctor if you think you are allergic or hypersensitive to
fluorescein or any other
ingredients in Fluorescein 100 mg/ml Solution for injection.
WARNINGS AND PRECAUTIONS
TELL YOUR DOCTOR BEFORE YOU ARE GIVEN FLUORESCEIN 100 MG/ML SOLUTION
FOR INJECTION
-
IF YOU HAVE PRE-EXISTING CONDITIONS SUCH AS CARDIOVASCULAR DISEASE OR
DIABETES MELLITUS.
-
IF YOU HAVE IMPAIRED KIDNEY FUNCTION.
Fluorescein angiography testing may weaken or
damage kidney function which can be a risk for s

Summary of Product characteristics

Health Products Regulatory Authority
28 July 2023
CRN00DQYJ
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fluorescein 100 mg/ml Solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution contains 100 mg fluorescein (as 113.2 mg fluorescein
sodium)
One 5 ml vial contains 500 mg fluorescein (as 566 mg fluorescein
sodium)
Excipient with known effect:
Sodium (as fluorescein sodium and sodium hydroxide) 3.15 mmol dose.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection
Clear, red-orange solution
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
For fluorescein angiography of the ocular fundus.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults, including elderly:
Inject 5 ml of Fluorescein 100 mg/ml Solution for injection rapidly
into the antecubital vein after taking precautions to avoid
extravasation. In cases when highly sensitive imaging systems e.g.,
scanning laser ophthalmoscope are used, the dose of this
product should be reduced to 2 ml of Fluorescein 100 mg/ml solution
for injection.
Paediatric population:
Fluorescein 100 mg/ml Solution for injection has not been studied in
children and dose-adaptation data are not available.
Therefore, Fluorescein 100 mg/ml Solution for injection should not be
used in patients below 18 years as efficacy and safety in
this group have not been established.
Patients with renal insufficiency (glomerular filtration rate below
20ml/min):
Limited experience in renally impaired subjects (glomerular filtration
rate below 20 ml/min) suggests that, in general, no dose
adjustment is required although a longer excretion rate in patients
with renal impairment is possible (see section 5.2).
Dialysed patients: Reduce dose to 2.5 ml (half a vial).
METHOD OF ADMINISTRATION AND FLUORESCENCE ANGIOGRAPHY
Fluorescein 100 mg/ml solution for injection should be used
exclusively by qualified physicians with technical expertise in
performing and interpretin